FDA 510(k)

ArtUs

K-Number: K211248 · 2022-02-11

Decision Date2022-02-11

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ArtUs is the device name listed in this FDA 510(k) record. The listed applicant is Telemed. It received FDA 510(k) clearance on 2022-02-11 under 510(k) number K211248. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArtUs?

ArtUs is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is Telemed. The 510(k) number is K211248.

When did ArtUs receive FDA 510(k) clearance?

ArtUs received FDA 510(k) clearance on 2022-02-11, under 510(k) number K211248.

Who is the listed applicant for ArtUs?

The FDA 510(k) record lists Telemed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArtUs?

The FDA product code for ArtUs is IYN.

Other records listing Telemed as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IYN)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.